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FDA Phase III Approval Historical Stock Performance

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Ventrus Biosciences’ Vision = to educate the investor community on what an FDA Stage III approval could do to a stock currently trading at $7.59 pps

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FDA Phase III Approval Historical Stock Performance

  1. 1. FDA Phase III Approval Historical Stock Performance<br />The Path to Liquidity<br />
  2. 2. To understand what Stage III FDA Approval has Historically done to the share price we can take a look at the below relative companies <br />2<br />
  3. 3. DHTH – April 21st 2010<br />Oncology-focused medical device manufacturer Delcath Systems, Inc. (DCTH), said that its Phase III National Cancer Institute or NCI-led multi-center clinical trial has successfully met the study's primary endpoint of extended hepatic progression-free survival or hPFS in patients with cancer to the liver based on an independently corroborated intent-to-treat analysis. <br />
  4. 4. DCTH Performance Between March 15 - April 20 <br />DCTH: Moved from $6.09 to $10.60 (74.06% return)<br />S&P 500 Index: Moved from 1150.51 to 1207.17 (4.92% return)<br />Nasdaq Biotech Index: Moved from 935.19 to 952.45 (1.85% return)<br />A Month before leading up to announcement<br />
  5. 5. DCTH Announces FDA Stage III Approval <br />DCTH: Moved from $10.60 to $10.85 (2.36% return)<br />S&P 500 Index: Moved from 1207.17 to 1205.94 (-0.10% return)<br />Nasdaq Biotech Index: Moved from 952.45 to 935.58 (-1.77% return)<br />Aril 20th 2010<br />
  6. 6. Performance Between April 21 - July 21 <br />DCTH: $10.85 to $7.19 (-33.73% return)<br />S&P 500 Index: 1205.94 to 1069.59 (-11.31% return)<br />Nasdaq Biotech Index: 935.58 to 799.84 (-14.51% return)<br />Note - Significant event dated June 7, 2010: Delcath Systems Inc. shares fell 26% after Cowen & Co. said the company's experimental chemotherapy system drew criticism at an oncology meeting. http://www.marketwatch.com/story/mondays-biggest-gaining-and-declining-stocks-2010-06-07<br />3 Months after the announcement<br />
  7. 7. AMRN – November 29th 2010<br />Reported positive, statistically significant top-line results from the MARINE study, its first Phase 3 clinical trial of lead drug candidate AMR101. The MARINE study, investigating AMR101 as a treatment for very high triglycerides (greater-than or equal to 500 mg/dL), met its primary efficacy endpoints as defined in the clinical trial protocol and demonstrated a positive safety profile. The Company believes that AMR101 has the potential to be the best-in-class product for this indication and that the MARINE study results may support additional patentable claims that could further protect the Company's rights to this product through 2030. <br />
  8. 8. AMRN Performance Between Oct 28th 2010 – Nov 26th 2010 <br />AMRN: Moved from $3.10 to $3.55 (14.52% return)<br />S&P 500 Index: Moved from 1183.78 to 1189.4 (0.47% return)<br />Nasdaq Biotech Index: Moved from 929.75 to 924.6 (-0.55% return)<br />A Month before leading up to announcement<br />
  9. 9. AMRN Announces FDA Stage III Approval <br />AMRN: Moved from $3.55 to $5.85 (64.79% return)<br />S&P 500 Index: Moved from 1189.4 to 1187.76 (-0.14% return)<br />Nasdaq Biotech Index: Moved from 924.6 to 917.68 (-0.75% return)<br />November 29th 2010<br />
  10. 10. AMRN Performance Between Nov 29th 2010 – Feb 25th 2010 <br />AMRN: Moved from $5.85 to $8.09 (38.29% return)<br />S&P 500 Index: Moved from 1187.76 to 1319.88 (11.12% return)<br />Nasdaq Biotech Index: Moved from 917.68 to 982.48 (7.06% return)<br />3 Months after the announcement<br />
  11. 11. CORT – December 22nd 2010<br />Corcept Therapeutics Incorporated (NASDAQ: CORT) today announced positive top-line results from its Phase 3 study of CORLUX for the treatment of Cushing's Syndrome. The study evaluated the response of two patient groups to CORLUX treatment: one included patients who were glucose intolerant and one included patients who were hypertensive. Statistically significant improvement in the primary endpoint was achieved for both groups: with 60% responding in the glucose intolerant group and 43% in the hypertensive group. An initial review of safety data indicates that CORLUX was well tolerated by Cushing's Syndrome patients in this Phase 3 study. <br />
  12. 12. CORT Performance Between Nov 19th 2010 – Dec 21st 2010 <br />CORT: Moved from $3.52 to $4.19 (19.03% return)<br />S&P 500 Index: Moved from 1199.73 to 1254.6 (4.57% return)<br />Nasdaq Biotech Index: Moved from 919.93 to 983.97 (6.96% return)<br />A Month before leading up to announcement<br />
  13. 13. CORT Announces FDA Stage III Approval <br />CORT: Moved from $4.19 to $3.90 (-6.92% return)<br />S&P 500: Moved from 1254.6 to 1258.84 (0.34% return)<br />Nasdaq Biotech Index: Moved from 983.97 to 982.98 (-0.10% return)<br />December 22, 2010 <br />
  14. 14. CORT Performance Between Dec 22, 2010 - Feb 25, 2011 <br />CORT: Moved from $3.90 to $3.79 (-2.82% return)<br />S&P 500 Index: Moved from 1258.84 to 1319.88 (4.85% return)<br />Nasdaq Biotech Index: Moved from 982.98 to 982.48 (-0.05% return)<br />Note - Buy The Rumor, Sell The News Price Action: The stock had a strong run-up to the announcement, but traders chose to sell the news announcement. "You are talking about a company that has been anticipating the data for some time and the buying rate was generally strong in the run-up from $3, a couple of months ago to $4.50," StifelNicolaus & Co analyst Annabel Samimy said. <br />Read more here: http://in.reuters.com/article/2010/12/22/corcept-idINSGE6BL0AD20101222<br />3 Months after the announcement<br />
  15. 15. ARIA – January 18, 2011 <br />Announced top-line data showing that ridaforolimus, an investigational oral mTOR inhibitor, met the primary endpoint of improved progression-free survival (PFS) compared to placebo in the Phase 3 SUCCEED trial conducted in patients with metastatic soft-tissue or bone sarcomas who previously had a favorable response to chemotherapy. Merck is currently developing ridaforolimus in multiple cancer indications under an exclusive license and collaboration agreement with ARIAD. <br />
  16. 16. ARIA Performance Between Dec 15, 2010 - Jan 14, 2011 <br />ARIA: Moved from $4.42 to $5.25 (18.78% return)<br />S&P 500 Index: Moved from 1235.23 to 1293.24 (4.70% return)<br />Nasdaq Biotech Index: Moved from 955.78 to 1001.44 (4.78% return)<br />A Month before leading up to announcement<br />
  17. 17. ARIA Announces FDA Stage III Approval <br />ARIA: Moved from $5.25 to $7.04 (34.10% return)<br />S&P 500: Moved from 1293.24 to 1295.02 (0.14% return)<br />Nasdaq Biotech Index: Moved from 1001.44 to 1010.69 (0.92% return)<br />January 18th 2010 <br />
  18. 18. ARIA Performance Between Jan 18th - Feb 25th 2011 <br />ARIA: Moved from $7.04 to $6.08 (-13.64% return)<br />S&P 500 Index: Moved from 1295.02 to 1319.88 (1.92% return)<br />Nasdaq Biotech Index: Moved from 1010.69 to 982.48 (-2.79% return)<br />3 Months after the announcement<br />
  19. 19. CHTP – December 20th 2010 <br />Chelsea Therapeutics International Ltd. announced that FDA may not require further efficacy studies for the new drug application filing for its Northera in symptomatic, neurogenic orthostatic hypotension or NOH associated with Parkinson's disease. The company further said it would accelerate the filing for new drug application. <br />
  20. 20. CHTP Performance Between Dec 1st 2010 - Dec 17th 2010 <br />CHTP: Moved from $5.34 to $6.01 (12.55% return)<br />S&P 500 Index: Moved from 1206.07 to 1243.91 (3.14% return)<br />Nasdaq Biotech Index: Moved from 920.16 to 978.98 (6.39% return)<br />A Month before leading up to announcement<br />
  21. 21. CHTP Announces FDA Stage III Approval <br />CHTP: Moved from $6.01 to $7.69 (27.95% return)<br />S&P 500 Index: Moved from 1243.91 to 1247.08 (0.25% return)<br />Nasdaq Biotech Index: Moved from 978.98 to 979.72 (0.08% return)<br />December 20th 2010 <br />
  22. 22. CHTP Performance Between Dec 20th 2010 - Feb 25th 2011 <br />CHTP: Moved from $7.69 to $4.32 (-43.82% return)<br />S&P 500: Moved from 1247.08 to 1319.88 (5.84% return)<br />Nasdaq Biotech Index: Moved from 979.72 to 982.48 (0.28% return)<br />Note: Since the announcement, Chelsea Therapeutics has announced that it plans to offer $35 million in shares of its common stock in a registered public offering pursuant to its existing shelf registration statement. This dilution seems to have dragged down the stock. (Read more here: http://www.rttnews.com/ArticleView.aspx?Id=1556190)<br />3 Months after the announcement<br />
  23. 23. REGN – November 22nd 2010 <br />Announced that in two parallel Phase 3 studies conducted by the company and Bayer HealthCare in patients with the neovascular form of age-related macular degeneration, or wet AMD, all regimens of VEGF Trap-Eye, including VEGF Trap-Eye dosed every two months, successfully met the primary endpoint compared to the current standard of care, ranibizumab dosed every month. <br />
  24. 24. REGN Performance Between Oct 19th 2010 - Nov 19th 2010 <br />REGN: Moved from $27.40 to $24.67 (-9.96% return)<br />S&P 500 Index: Moved from 1165.9 to 1199.73 (2.90% return)<br />Nasdaq Biotech Index: Moved from 914.75 to 919.93 (0.57% return)<br />A Month before leading up to announcement<br />
  25. 25. REGN Announces FDA Stage III Approval <br />REGN: 24.67 to 29.53 (19.70% return)<br />S&P 500 Index: 1199.73 to 1197.84 (-0.16% return)<br />Nasdaq Biotech Index: 919.93 to 924.63 (0.51% return)<br />November 22, 2010 <br />
  26. 26. REGN Performance Between Nov 22nd 2010 - Feb 25th 2011 <br />REGN: Moved from $29.53 to $37.00 (25.30% return)<br />S&P 500 Index: Moved from 1197.84 to 1319.88 (10.19% return)<br />Nasdaq Biotech Index: Moved from 924.63 to 982.48 (6.26% return)<br />3 Months after the announcement<br />
  27. 27. SGEN – September 27, 2010 <br />A robust 75 percent of Hodgkin's lymphoma patients in a pivotal trial responded to a cancer-targeting antibody developed by Seattle Genetics (SGEN.O), sending the company's shares up more than 17 percent on Monday. Results of the Phase III trial clear the way for an application for U.S. regulatory approval of the drug, called brentuximabvedotin, in the first half of 2011. <br />
  28. 28. SGEN Performance Between Aug 24th 2010 - Sep 24th 2010 <br />SGEN: $11.70 to $12.60 (3.93% return)<br />S&P 500 Index: 1051.87 to 1148.67 (9.20% return)<br />Nasdaq Biotech Index: 812 to 905.07 (11.46% return)<br />A Month before leading up to announcement<br />
  29. 29. SGEN Announces FDA Stage III Approval <br />SGEN: $12.16 to $14.30 (17.60% return)<br />S&P 500 Index: 1148.67 to 1142.16 (-0.57% return)<br />Nasdaq Biotech Index: 905.07 to 895.54 (-1.05% return)<br />September 27, 2010 <br />
  30. 30. SGEN Performance Between Sep 27th 2010 - Dec 27th 2010 <br /> SGEN: $14.30 to $15.71 (9.86% return)<br />S&P 500 Index: 1142.16 to 1257.54 (10.10% return)<br />Nasdaq Biotech Index: 895.54 to 984.75 (9.96% return)<br />3 Months after the announcement<br />
  31. 31. DNDN – April 29, 2010 <br />Dendreon Corp. (DNDN: News ) saw its prostate cancer vaccine Provenge pass muster with the FDA, which lifted its stock to a record high of $54.58. Provenge, which belongs to a new class of therapy known as active cellular immunotherapy, becomes the first therapeutic cancer vaccine to be approved by the FDA. It works by stimulating the immune system to recognize a protein known as the prostatic acid phosphatase or PAP, which is found in about 95% of all prostate cancer cells and attacks the cancer cells. <br />
  32. 32. DNDN Performance Between March 26th 2010 - April 28th 2010 <br />DNDN: Moved from $36.87 to $39.62 (7.46% return)<br />S&P 500 Index: Moved from 1166.59 to 1191.36 (2.12% return)<br />Nasdaq Biotech Index: Moved from 943.3 to 923.79 (-2.07% return)<br />A Month before leading up to announcement<br />
  33. 33. DNDN Announces FDA Stage III Approval <br />DNDN: $39.62 to $50.18 (26.65% return)<br />S&P 500 Index: 1191.36 to 1206.78 (1.29% return)<br />Nasdaq Biotech Index: 923.79 to 950.03 (2.84% return)<br />April 29, 2010 <br />
  34. 34. DNDN Performance Between April 29th 2010 and July 29th 2010 <br /> DNDN: $50.18 to $32.78 (-34.68% return)<br />S&P 500 Index: 1206.78 to 1101.53 (-8.72% return)<br />Nasdaq Biotech Index: 950.03 to 822.41 (-13.43% return)<br />3 Months after the announcement<br />
  35. 35. Get into NASDAQ: VTUS before they DO <br />IPO in December 2010<br />3.335 million shares at $6.00 per share<br />Exchange: Nasdaq (“VTUS”)<br />Capital Structure<br />Cash and Short‐term Investments $17.6 million<br />Debt $2.7 mm<br />Common Shares Outstanding 7.2 million (9.3 million fully diluted)<br />Market Cap ~$45 million<br />

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